High impedance active fixation electrode of an electrical medical lead

ABSTRACT

Electrical medical leads having active fixation electrodes, particularly helix electrodes intended to be screwed into body tissue, e.g., the heart, are disclosed having selectively applied insulation to optimize exposed electrode surface area and dispose the exposed electrode surface area toward tissue that is less traumatized by injury caused by screwing in the fixation helix. In a preferred fabrication method, an outer helical surface is masked by contact with a masking tube while a dielectric coating is applied to the inner helical surface of the coil turns of the helix, and the masking tube is removed when the dielectric coating has set. In one variation, at least one aperture is formed through the masking tube sidewall exposing an area of the outer helical surface thereby interrupting the uninsulated outer helical electrode.

TECHNICAL FIELD

The present invention relates to electrical medical leads having activefixation electrodes, particularly helix electrodes intended to bescrewed into body tissue, e.g., the heart, having selectively appliedinsulation to optimize exposed electrode surface area and dispose theexposed electrode surface area toward tissue that is less traumatized byinjury caused by screwing in the fixation helix.

BACKGROUND

Implantable medical electrical stimulation and/or sensing leads(electrical medical leads) are well known in the fields of tissuestimulation and monitoring, including cardiac pacing andcardioversion/defibrillation, and in other fields of electricalstimulation or monitoring of electrical signals or other physiologicparameters. In the field of cardiac stimulation and monitoring, theelectrodes of epicardial or endocardial cardiac leads are affixedagainst the epicardium or endocardium, respectively, or insertedtherethrough into the underlying myocardium of the heart wall.

Epicardial or myocardial cardiac leads, or simply epicardial leads, areimplanted by exposure of the epicardium of the heart typically through alimited thorocotomy or a more extensive surgical exposure made toperform other corrective procedures. Endocardial cardiac leads, orsimply endocardial leads, are implanted through a transvenous route tolocate one or more sensing and/or stimulation electrode along or at thedistal end of the lead in a desired implantation site in a chamber ofthe heart or a blood vessel of the heart. It is necessary to accuratelyposition the electrode surface against the endocardium or within themyocardium or coronary vessel at the implantation site.

A passive or active fixation mechanism is typically incorporated intothe distal end of permanent cardiac leads and is deployed at theimplantation site to maintain the distal end electrode in contact withthe endocardium or within the myocardium. Considerable effort has beenundertaken to develop passive and active fixation mechanisms that aresimple to use and are reliable in maintaining the distal electrodes inposition.

Active fixation mechanisms are designed to penetrate the epicardial orendocardial surface and lodge in the myocardium without perforating allthe way through the myocardium. The most widely used active fixationmechanism employs a helix, which typically also constitutes a pace/senseelectrode. Typically, a mechanism is used to shield the sharpened tip ofthe helix during the transvenous advancement into the desired heartchamber or coronary vessel or to the epicardial surface. In oneapproach, a retraction mechanism that retracts the helix into a distalcavity of the lead body as shown in U.S. Pat. Nos. 5,837,006 and6,298,272, for example, is employed. In another approach, a shroud,e.g., a plug of dissolvable biocompatible material as disclosed in U.S.Pat. No. 5,531,783, for example, is applied over and between the coilturns of the helix. In still another approach, the lead is introducedthrough the sheath of a guide catheter, as disclosed in U.S. Pat. No.6,408,214, for example, that is advanced to the implantation site. Thehelix is advanced from the sheath or out of the lead body or the plugdissolves when the desired implantation site is reached. In one manneror another, the helix is adapted to be rotated by some means from theproximal end of the lead body outside the patient's body in order toscrew the turns of the helix into the myocardium and permanently fix thepace/sense electrode.

Over the last 30 years, it has become possible to reduce endocardiallead body diameters from 10 to 12 French (3.3 to 4.0 mm) down to 2French (0.66 mm) presently through a variety of improvements inconductor and insulator materials and manufacturing techniques. The leadbodies of such small diameter, 2 French, endocardial leads are formedwithout a lumen that accommodates use of a stiffening stylet to assistin implantation.

Such a small diameter endocardial lead is formed with an active fixationhelix that extends distally and axially in alignment with the lead bodyto a sharpened distal tip and that has a helix diameter substantiallyequal to the lead body diameter. The fixation helix does not necessarilyincrease the overall diameter of the endocardial lead, and fixation isrelatively robust once the helix is screwed into the myocardium.Typically, but not necessarily, the fixation helix is electricallyconnected to a lead conductor and functions as a pace/sense electrode.In some cases, the lead body encloses one or more helical coiled orstranded wire conductor and lacks a lumen.

When the fixation helix is used as a pace/sense electrode, the surfacearea of the fixation helix must be controlled within a range thathistorically has been between 6-10 mm², typically 8 mm². The fixationhelix outer diameter approximates the lead body diameter, and thefixation helix typically has more than one coil turn. More recent, smalldiameter fixation helices have surface areas in the range of 2.0 mm² to5.0 mm² typically 4.0 mm². The number of turns and length of thefixation helix is selected to avoid perforation through the heart wall.The exposed electrode surface must be within the myocardium rather thanexposed outside the heart or inside a heart chamber.

Consequently, it is conventional to coat a part or parts of the fixationhelix with electrical insulation to control the exposed surface area andto ensure that the exposed portion of the helix remains within themyocardium when the helix is properly screwed in. See, for example, U.S.Pat. Nos. 4,000,745, 4,010,758, 5,143,090, and 6,501,994 and U.S. PatentApplication Publication Nos. 2003/0060868 and 2003/0163184. Electricallyinsulating coatings are also applied to portions of barbed electrodes ofepicardial leads as shown, for example in commonly assigned U.S. Pat.No. 4,313,448. Electrical insulation of a fixation helix that is notemployed as a pace/sense electrode is shown, for example, in U.S. Pat.No. 4,662,382. Various forms of selective electrical insulation of othershapes of pace/sense electrodes are shown in U.S. Pat. Nos. 4,026,303and 6,526,321 and in EP Publication No. 0 042 551.

The dielectric, biocompatible, insulating coatings of choice haveincluded silicone rubber and non-thrombogenic compounds such as ParyleneC™ parylene, and various polyurethanes, polyacrylates (includingpolymethacrylates), polyesters, polyamides, polyethers, polysiloxanes,polyepoxide resins and the like. Cross-linked polymers within theseclasses may be preferred for their resistance to breakdown and theirphysical durability. Parylene coatings on the surfaces of implantablemedical devices have been widely accepted, and the deposition of aparylene coating on a pace/sense electrode can be readily effected usinga parylene vacuum deposition system that delivers poly-paraxylylene intoa vacuum chamber containing the targeted electrode. The portions of thedeposited parylene coating can be etched away as disclosed in theabove-referenced '321 patent to expose the pace/sense electrode surface.

The ideal electrode impedance for chronic pacing across theelectrode-tissue interface is in the range of 800 to 1,000 ohms. Forexample, the impedances reported in the above-referenced '994 patent areabout 800 ohms measured during chronic implantation. The perforation ofthe myocardium by the fixation helix causes inflammation and cell death,particularly of myocardial cells between the turns of the helix andwithin the helix lumen, and impedance rises for a time followingimplantation to about 1200 ohms, for example, before falling to thechronic impedance level. Cell death and substitution of scar tissue forexcitable myocardial cells is responsible for the observed impedancechanges. Steroid eluting coatings and devices are commonly incorporatedinto the distal end of the lead body to counter post-implantationimpedance rise as described in the above-referenced '994 patent and inU.S. Pat. No. 5,324,325, for example.

Pace/sense electrodes are typically formed of platinum or platinumiridium alloys that are bio-compatible and bio-stable during chronicimplantation and delivery of pacing pulses. Consequently, fixationhelices used as pace/sense electrodes are formed of platinum or platinumiridium wire wound into the helical shape to have one or more coil turnterminating in a sharpened tip. It is also common practice to surfacetreat or etch the electrode surface area of helical screw-in electrodesor to coat the electrode surface area with platinum black or a platinummetal oxide to create a surface texture that enhances thecharacteristics of the tissue-electrode interface to decrease post pulsedelivery polarization and stabilizes impedance changes, as disclosed inU.S. Pat. No. 4,762,136, for example.

It is not convenient to surface treat the fixation helix, coat thesurface treated helix with a dielectric insulating layer, and thenselectively etch away the insulating layer to expose the pace/senseelectrode surface as suggested in the above-referenced '321 patent,since the etching may damage an electrode coating or surface treatment.

Moreover, the selective insulation techniques and resulting electrodesurface areas on pace/sense screw-in electrodes disclosed in the priorart fail to address the injury and cell death occurring within the lumenof the fixation helix.

SUMMARY

The methods of fabrication of fixation helices of the present inventionaddress these issues and provides a fixation helix having selectivelyapplied insulation to optimize exposed electrode surface area anddispose the exposed electrode surface area toward tissue that is lesstraumatized by injury caused by screwing the fixation helix into thetissue. The methods of the present invention may be applied to any ofthe above-described helices of endocardial and epicardial leads.

A preferred embodiment of a fixation helix of the present invention hasat least one turn, wherein an inner spiral or helical surface iselectrically insulated and an outer spiral or helical surface is exposedto function as a pace/sense electrode exposed to myocardial cellssurrounding the turns of the helix.

In a preferred fabrication method, the outer helical surface is maskedwhen a dielectric coating is applied to the inner helical surface, andthe masking is removed when the dielectric coating has set. In oneapproach, the helix is fitted into the lumen of a resilient masking tubesuch that the lumen surface bears snugly against the outer helicalsurface of the helix. The dielectric material is directed into thecoaxially aligned helix lumen and tube lumen and forms a dielectriccoating on the inner helical surface of the coil turns of the helix. Theresilient masking tube is then removed, as by slitting through thetubing sidewall and peeling the tubing from the helix to expose theuncoated outer helical surface.

In one variation, at least one aperture is formed through the maskingtube side wall exposing an area of the outer helical surface. Theuninsulated outer helical electrode is thereby rendered non-continuousthrough its length.

Advantageously, the entire surface of the fixation helix may be surfacetreated in any of the conventional ways or coated with any of theconventional materials for optimizing impedance, reducing polarization,reducing inflammation, and enhancing the electrode-tissue interfacebefore the helix is fitted into the lumen of the masking tube. Thesurface treatment or coating is not damaged by contact with the maskingtube during deposition of the dielectric layer. Alternatively, theuninsulated outer helical electrode surface may be treated or coatedfollowing deposition of the insulating material.

Furthermore, the entire surface of the fixation helix or the insulatedsurface of the fixation helix may be coated with or incorporate asteroid.

The exposed outer helical electrode is directed toward viable, excitablemyocardial cells, and battery energy can be conserved due to as pacingenergy is directed away from traumatized cells within the helix lumenand between the spiral turns. The exposed electrode surface area can besubstantially reduced even for a small diameter fixation helix toachieve an optimal impedance due to the outward orientation of the outerhelical electrode surface that avoids delivering stimulation energy totraumatized tissue or myocardial cells within the helix lumen or betweenthe adjacent facing surfaces of the coil turns.

This summary of the invention and the advantages and features thereofhave been presented here simply to point out some of the ways that theinvention overcomes difficulties presented in the prior art and todistinguish the invention from the prior art and is not intended tooperate in any manner as a limitation on the interpretation of claimsthat are presented initially in the patent application and that areultimately granted.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other advantages and features of the present invention will bereadily appreciated as the same becomes better understood by referenceto the following detailed description when considered in connection withthe accompanying drawings, in which like reference numerals designatelike parts throughout the figures thereof and wherein:

FIG. 1 is a schematic diagram of a heart from an anterior perspectiveillustrating the coronary venous system about an epicardial surface ofthe heart, including dashed lines depicting a portion of coronary venoussystem on an opposite, posterior epicardial surface of the heart;

FIG. 2 is a plan view, in partial exposed section, of a pacing leadhaving a distal fixation helix functioning as a pace/sense electrode andhaving selectively applied insulation to optimize exposed electrodesurface area and dispose the exposed electrode surface area towardmyocardial tissue that is less traumatized by injury caused by screwingthe fixation helix into the myocardium;

FIG. 3 is a plan view of the distal fixation helix mounted for surfacecoating prior to assembly to the lead body of the pacing lead of FIG. 2;

FIG. 4 is an end view of the distal fixation helix of FIG. 3;

FIG. 5 is a plan view of the distal fixation helix of FIGS. 3 and 4fitted within a lumen of a masking tube during the deposition of aninsulating coating over the inner helical surface of the turns of thefixation helix;

FIG. 6 is an end view of the distal fixation helix of FIGS. 3 and 4fitted within the lumen of the masking tube during the deposition of theinsulating coating;

FIG. 7 is a plan view of the distal fixation helix upon removal of themasking tube following deposition of an insulating coating over theinner helical surface of the turns of the fixation helix and showing theexposed pace/sense electrode on the outer helical surface of the turnsof the fixation helix;

FIG. 8 is an end view of the distal fixation helix of FIG. 7;

FIG. 9 is a plan view of a further embodiment of the distal fixationhelix fitted within a lumen of a masking tube having an aperture throughthe tube side wall during the deposition of an insulating coating overthe inner helical surface of the turns of the fixation helix anddiscrete areas of the outer helical surface;

FIG. 10 is an end view of the distal fixation helix of FIG. 9 fittedwithin the lumen of the masking tube during the deposition of theinsulating coating;

FIG. 11 is a plan view of the distal fixation helix upon removal of themasking tube following deposition of an insulating coating over theinner helical surface of the turns of the fixation helix and showing theexposed pace/sense electrode on the outer helical surface of the turnsof the fixation helix; and

FIG. 12 is an end view of the distal fixation helix of FIG. 11.

The drawing figures are not necessarily to scale.

DETAILED DESCRIPTION

In the following detailed description, references are made toillustrative embodiments for carrying out the invention. It isunderstood that other embodiments may be utilized without departing fromthe scope of the invention. The invention and its preferred embodimentsmay be employed in unipolar, bipolar or multi-polar, endocardial,cardiac pacing leads, cardioversion/defibrillation leads or monitoringleads having at least one pace/sense electrode formed as part of thedistal fixation helix that is to be screwed into the myocardium. It willbe understood that other sensors for sensing a physiologic parameter maybe incorporated into the lead body.

An insulated electrical conductor extending proximally through the leadbody to connector element of a lead proximal end connector assembly iscoupled to each such pace/sense electrode, sense electrode,cardioversion/defibrillation electrode and sensor. The proximalconnector assembly is adapted to be coupled to the connector assembly ofan external medical device, including an external pacemaker or monitor,or an implantable medical device, including an implantable pulsegenerator (IPG) for pacing, cardioversion/defibrillation (or both) or animplantable monitor.

The methods of the present invention are particularly useful inoptimizing electrode surface area on the distal fixation helix toprovide optimal pacing and sensing impedance and to dispose the exposedelectrode surface area toward myocardial tissue that is less traumatizedby injury caused by screwing the fixation helix into the myocardium.

The cardiac lead of the preferred embodiment of the invention can beintroduced in a variety of ways to the epicardial or endocardial surfaceof the heart or into a coronary blood vessel so that the distal fixationhelix can be screwed into the myocardium. Epicardial implantation sites,particularly left ventricular sites can be accessed in a variety of waysinvolving surgical creation of a thoracic passage and use of anintroducer and guide catheter. Endocardial implantation sites includethe apex of the right ventricle, the atrial appendage or at other sitedof the right atrium, and into the coronary sinus.

For convenience, exemplary endocardial implantation sites are depictedin FIG. 1, particularly sites within the coronary sinus and vesselsbranching therefrom. FIG. 1 is a schematic diagram of a heart 6 from ananterior perspective illustrating a coronary venous system about anepicardial surface, including dashed lines depicting a portion ofcoronary venous system on an opposite, posterior surface of the heart 6.FIG. 1 also illustrates a pathway, defined by arrow ‘A’, which may befollowed in order to place a cardiac lead within CS 4, extending from avenous access site (not shown) through the superior vena cava (SVC) 1into the right atrium (RA) 2 of heart 6 and from the RA 2 into the CS 4through a coronary sinus ostium (CS Os) 3.

As illustrated in FIG. 1, the coronary venous system of a heart 6includes the CS 4 and vessels branching therefrom including the middlecardiac vein (MCV) 13, the posterior cardiac vein (PCV) 12, theposterior-lateral cardiac vein (PLV) 11, the great cardiac vein (GCV) 9,and the lateral cardiac vein (LCV) 10 all branching away from the CS 4.Generally speaking, the distal portion of the CS 4 and the branchingvessels including at least portions of the MCV 13, PCV 12, the PLV 11,the GCV 9, and the LCV 10 overlie the or are embedded within theepicardium that defines outer surface of the heart 6 and encases heartmuscle or myocardium. Portions of the epicardium are spaced from asurrounding pericardial sac or pericardium (not shown), whereby apericardial space surrounds the spaced epicardium of heart 6. Thus, thevessel walls of the distal portion of the CS 4 and the branching vesselsincluding at least portions of the MCV 13, PCV 12, the PLV 11, the GCV9, and the LCV 10 are partially exposed to the pericardial space oradhered to the pericardium and are partially embedded against theunderlying myocardium. For convenience of terminology, the vessel wallsthat are disposed toward the pericardium are referred to as disposed“away from the heart”, whereas the vessel walls that are disposed towardthe myocardium are referred to as disposed “toward the heart”.

In patients suffering from heart failure, a CS lead of the typesdescribed above is advanced through the pathway “A” extending throughthe SVC 1 and RA 2 into the CS 4 to dispose one or a pair of distalpace/sense electrodes at an LV site(s) within one of the vesselsbranching from the CS 4. An RV lead is advanced through the SVC 1, theRA 2, the tricuspid valve, and the distal pace/sense electrode(s) isaffixed at an RV pace/sense site(s) of the RV 8, e.g., in the RV apex oralong the septum separating the RV and LV chambers. The RV lead can takeany of the functions known in the art preferably having an active orpassive fixation mechanism.

The proximal connectors of the CS lead and the RV lead are coupled to aconnector header of a pacing IPG or an ICD IPG (not shown) implantedsubcutaneously. The IPG is capable of sensing and processing cardiacsignals detected at the pace/sense site(s) to provide synchronized RVand LV pacing at the pace/sense sites as needed. The pacing and sensingfunctions of such an IPG that provides synchronous activation of the RV8 and LV 7 in order to improve the hemodynamic output of the heart 6 aredisclosed in commonly assigned U.S. Pat. No. 5,902,324, for example, andare embodied in the MEDTRONICO InSync Marquis™ ICD IPG, for example.

Hemodynamic output is enhanced when the CS pace/sense electrode(s) siteis selected within a late activated region of LV 7. Late activatedregions of the LV 7 are found within the myocardium underlying the PLV11, the LCV 10, the GCV 9, or the CS 4 near a junction with the GCV 9.Moreover, pacing and sensing functions are optimized when the pace/senseelectrode(s) are disposed in intimate contact with excitable myocardialtissue. Thus, the CS pace/sense electrode(s) are to be advanced throughthe pathway “A” to the site of a selected late activated region andaffixed so that the CS pace/sense electrodes are disposed toward theheart 6 and not disposed away from the heart 6. The fixation isaccomplished by use of an active fixation helix that is directed towardthe heart 6 and screwed through the vessel wall and into the myocardium.

The lead body of an endocardial lead introduced to a fixation sitewithin the RA 2, the RV 8, and the CS 4, and vessels branchingtherefrom, typically comprises one or more insulated conductive wiresurrounded by an insulating outer sheath. Each conductive wire couples aproximal lead connector element with a distal stimulation and/or sensingelectrode. Epicardial and endocardial leads having a single stimulationand/or sensing electrode at the lead distal end, a single conductor, anda single connector element are referred to as unipolar leads. Epicardialand endocardial leads having two or more stimulation and/or sensingelectrodes at the lead distal end, two or more respective conductors,and two or more respective connector elements are referred to as bipolarleads or multi-polar leads, respectively.

A typical example of an active fixation cardiac lead 20 in which thepresent invention is implemented is schematically illustrated in FIG. 2.The cardiac lead 20 has an elongated lead body 21 that extends between aproximal connector 22 and a distal end 24. A helical fixation element orhelix 25 having a sharpened piercing tip 251 extends distally from leadbody distal end 24. The cardiac lead 20 can be configured as a unipolaror a bipolar or multi-polar lead for both endocardial or epicardialimplantation. The distal fixation helix 25 of the cardiac lead can beaffixed into the myocardium at any site of the RA 2 or the RV 8, or anysite accessed by advancement through pathway “A” into the CS or vesselsbranching therefrom. In addition, the cardiac lead 20 can be introducedto an epicardial implantation site in the manner described above, forexample.

Pacing lead 20 is essentially iso-diametric along its length, with anouter diameter of lead body 21 and fixation helix 25 betweenapproximately 1 French (0.33 mm) to 3 French (1.00 mm). Since lead body21 does not include an inner lumen, the outer diameter of lead body 21is reduced in this example. However, it will be understood that thefeatures of the present invention can be employed with lead bodies thatinclude one or more lumen.

In this example depicted in FIG. 2, lead body 21 is constructed of astranded conductive or non-conductive filament cable 28 disposed withinan inner sheath lumen of an inner sheath 29, which in turn extendsthrough the coil lumen of a coil 27. The assembly of the coil 27, innersheath 29, and cable 28 is fitted through an outer sheath lumen of anouter sheath 26.

Coil 27 is formed of any bio-stable and biocompatible material that issufficiently stiff to provide adequate torque transfer from proximalconnector assembly 22 to fixation element 25 at distal end 24 of cardiaclead 20. When coil 27 functions as a lead conductor, coil 27 ispreferably formed of single or multiple wire filars made of MP35-Nalloy, well known in the art, or any other bio-stable and biocompatiblematerial that is capable of reliably conducting electrical current afterhaving been subjected to numerous, repeated bending and torsionalstresses.

Inner cable 28 is formed from synthetic filaments or conductive metallicwires, when inner cable functions as a lead conductor. The proximal anddistal ends of inner cable 28 are coupled to connector pin 23 or withinconnector assembly 22 and fixation helix 25, respectively, to providetensile strength to lead body 21.

Outer sheath 26 is formed of either a silicone rubber or polyurethane,well known in the art, or any other flexible, bio-stable andbiocompatible, electrically insulating, polymer material. Inner sheath29 is similarly formed of a bio-stable and biocompatible flexiblepolymer coating or tube that protects inner cable 28 from mechanicalstresses or hydrolytic degradation and electrically insulates innercable 28 from contact with wire coil 27. Inner sheath 29 can be formedof flexible, bio-stable and biocompatible electrically insulatingmaterials known in the art, including silicone rubber compounds,polyurethanes, and fluoropolymers.

In both unipolar and bipolar cardiac lead embodiments, the proximalconnector assembly 22 includes a connector pin 23 that is typicallyelectrically connected with the distal fixation helix 25 when the distalfixation helix 25 functions as a pace/sense electrode. In a bipolarcardiac lead embodiment, the proximal connector assembly 22 includes aconnector ring 32 (shown with dashed lines) that is electrically coupledto a ring-shaped pace/sense electrode 30 (shown with dashed lines)supported by outer sheath 26 proximal to fixation helix 25. Theconnector assembly 22 is shaped to be inserted into a bore of aconnector block of the connector header of an IPG as described above tomake an electrical connection between the distal pace/sense electrode(s)and IPG sensing and/or pacing pulse generating circuitry. The fixationhelix 25 is adapted to be screwed into the myocardium, as describedbelow, by rotation of lead body 21 from the proximal connector assembly22 when piercing tip 251 is advanced to and oriented toward a fixationsite.

In a unipolar embodiment of cardiac lead 20, the inner cable 28 isnonconductive, a proximal end of coil 27 is coupled to connector pin 23,and a distal end of coil 27 is coupled to the proximal end of fixationhelix 25. The proximal and distal ends of coil 27 are welded or crimpedto the connector pin 23 and fixation helix 25, respectively, usingcommon welding or crimping techniques known in the art. The proximal anddistal ends of inner cable 28 are crimped to the connector pin 23 orconnector assembly 22 and fixation helix 25, respectively, using commonwelding or crimping techniques known in the art.

In an alternate unipolar embodiment wherein the inner cable isnonconductive, helix fixation element 25 simply provides fixation anddoes not function as a pace/sense electrode. The proximal end of coil 27is coupled to connector pin 23, and the distal end of coil 27 is coupledto the ring-shaped pace/sense electrode 30 incorporated coaxially abouta distal portion of lead body 21. The spacing 31 between ring-shapedpace/sense electrode 30 and fixation helix 25 is less than approximately0.02 inches in order to locate ring-shaped pace/sense electrode 30 closeenough to a fixation site for tissue contact when fixation helix 25 isfixed into the myocardium.

In a further alternate unipolar embodiment of cardiac lead 20, innercable 28 is electrically conductive, and the proximal and distal cableends are electrically coupled by crimping or welding or other knowntechniques to connector pin 23 and helix fixation element 25,respectively. Inner sheath 29 electrically insulates inner cable 28 fromcoil 27, which acts only as a structural element to provide torsionalstiffness to lead body 21. Alternatively, the proximal and distal endsof the conductive inner cable 28 and the wire coil 27 can beelectrically connected together to provide a redundant unipolar leadconductors. Conductive inner cable 28 is preferably formed from wirestrands or filaments made of MP35-N alloy, well known in the art, or anyother bio-stable and biocompatible material that is capable of reliablyconducting electrical current after having been subjected to numerous,repeated bending and torsional stresses.

In a bipolar embodiment of cardiac lead 20, both coil 27 and inner cable28 are lead conductors as described above, that are electricallyinsulated from one another by inner sheath 29. The ring-shapedpace/sense electrode 30 is preferably formed of a platinum alloy butother materials may also be used, including but not limited to suchmaterials as palladium, titanium, tantalum, rhodium, iridium, carbon,vitreous carbon and alloys, oxides and nitrides of such metals or otherconductive or even semi-conductive materials. Of course, some materialsare incompatible with others and may not be effectively used together.The limitations of specific materials for use with others are well knownin the art. The proximal and distal ends of coil 27 are electrically andmechanically coupled by crimping or welding to the connector ring 32 andthe ring-shaped pace/sense electrode 30, respectively. The proximal anddistal ends of the inner cable 28 are electrically and mechanicallycoupled by crimping or welding to connector pin 23 and distal fixationhelix 25, respectively.

The spacing 31 between ring-shaped pace/sense electrode 30 and fixationhelix 25 is between approximately 0.2 inches and 0.4 inches, a rangewell known in the pacing art for inter-electrode bipolar pace/senseelectrode spacing.

The exemplary active fixation cardiac lead 20 can also be formed havingan elongated cardioversion/defibrillation (C/D) electrode extendingproximally a predetermined distance along the outer sheath 21 from a C/Delectrode distal end located proximal to distal lead end 24. Theproximal and distal ends of the wire coil 27 would be electrically andmechanically coupled to the connector ring 32 and the elongated C/Delectrode, respectively. The proximal and distal ends of the inner cable28 would be electrically and mechanically coupled by crimping or weldingto connector pin 23 and distal fixation helix 25, respectively.

A means for steroid elution may be incorporated into any of theaforementioned embodiments of the exemplary active fixation cardiac lead20 near distal end 24 to counter post-implantation impedance rise. Suchsteroid elution means may take the form of a monolithic controlledrelease device (MCRD), preferably constructed from silicone rubber andloaded with a derivative of dexamethasone, such as the water-solublesteroid dexamethasone sodium phosphate. MCRD construction and methods offabrication are found in commonly assigned U.S. Pat. Nos. 4,506,680,4,577,642, 4,606,118, 4,711,251, and 5,282,844. Alternatively a steroidcoating containing a no more than sparingly water-soluble steroid suchas beclomethasone diproprionate or dexamethasone acetate may be appliedto surfaces of ring-shaped pace/sense electrode 30 and/or fixation helix25. A steroid coating composition and method of application is found incommonly assigned U.S. Pat. No. 5,987,746. The steroid coating may beapplied directly to surfaces or portions of surfaces preservingstructural integrity of ring-shaped pace/sense electrode 30 and/orfixation helix 25 and taking up less space than an MCRD.

Such an exemplary active fixation cardiac lead 20 can be employedadvantageously as a CS lead through the use of a guide catheter advancedthrough the pathway “A” of FIG. 1 to locate the fixation helix 25 at afixation site in the coronary vasculature and to aim the helix tip 251toward the heart before the connector assembly 22 is rotated to screwthe fixation helix 25 through the vessel wall and into the myocardium.

In one approach shown, for example, in commonly assigned U.S. Pat. Nos.5,246,014 and 6,408,214, the lead body is enclosed within the lumen of afurther sheath or introducer, and the lead and introducer are disposedwithin the lumen of the guide catheter. The fixation helix is locatedwithin the catheter lumen during advancement of the lead distal endfixation helix through the transvenous pathway and heart chamber orcoronary vessel to dispose the fixation helix near the implantationsite.

Similar approaches have been undertaken to advance a fixation helixthrough minimally invasive surgical exposure of the pericardial sac tothe epicardium of the heart and to screw the fixation helix into themyocardium. Early examples of such epicardial screw-in leads are shown,for example, in U.S. Pat. Nos. 3,472,234, 3,416,534, 3,737,579,4,000,745, and 4,010,758, for example.

As shown in FIG. 2, the fixation helix 25 extends from a helixattachment end to a distal end terminating in a helix tip 35 shaped topenetrate body tissue when the helix 25 is screwed into body tissue tosecure fixation to the implantation site. In accordance with the presentinvention, the fixation helix 25 is fabricated following the exemplarymethod depicted in FIGS. 3-8 or the variation method depicted in FIGS.9-12 having a layer or coating 42 or 142 of insulating material coveringat least a portion of an inner helical surface of each coil turndisposed toward the helix lumen. After the coating 42 or 142 is applied,at least a portion of an uncoated outer helical surface of each coilturn comprises an uninsulated outer helical electrode 40 or 140. Theouter helical electrode 40 or 140 is disposed toward body tissue awayfrom the helix lumen to function as a stimulation and sensing electrodeupon implantation.

When fixation helix 25 functions as a pace/sense electrode of a pacinglead, as in any of the alternate endocardial and epicardial, unipolarand bipolar or multi-polar embodiments described above, fixation helix25 is preferably formed of a platinum iridium alloy wire 36 shown inFIG. 3. It is understood that other biocompatible and bio-stablematerials may also be used to form wire 36, including but not limited tosuch materials as palladium, titanium, tantalum, rhodium, carbon,vitreous carbon and alloys, oxides and nitrides of such metals or otherconductive or even semi-conductive materials well known in the art.

As shown in FIG. 3, the conductive wire 36 is preferably formed into acoil 37 comprising at least one coil turn (in this example, about threeturns) wound to define a helix lumen within the inner diameter ID of thecoil turns. The coil 37 extends from a support used during helixfabrication or a crimp tube 50 that will be used to attach the fixationhelix 25 to the distal end of a conductor within the lead body. The coil37 is wound about the crimp tube 50, in this example, so that fixationhelix attachment end is formed. The free end of the coil 37 is shaped toform the helix tip 35 that penetrates body tissue when the helix 25 isscrewed into body tissue to secure fixation to the implantation site.Thus, a plurality of coil turns are depicted in FIG. 3 that are spacewound through a coil length CL in a constant pitch P and coil outerdiameter OD defining the helix outer diameter and a coil inner diameterID defining the helix lumen diameter. The space winding ensures that aspace exists between facing surfaces of adjacent coil turns.

In one preferred embodiment, the wire 36 has a diameter of 0.25 mm, thepitch P is 1.0 mm, the coil OD is 1.6 mm, the coil ID is 1.1 mm and thecoil length CL is 1.8 mm providing a helix surface area of 4.2 mm².These dimensions can be varied to provide helix surface areas in therange of 2.0 mm² to 10.0 mm². The present invention can be employed toselectively reduce the electrode surface area of a relatively largediameter fixation helix that provides robust fixation whileadvantageously orienting the electrode surface area toward viable,excitable body tissue at an implantation site. For example, theelectrode surface area of a fixation helix having a total surface areaof about 4.2 mm² can be selected to be between about 0.8 mm² to 2.1 mm².About 10% to about 50% of the surface area helix surface area can becoated in accordance with the present invention.

The surface of the coil turns of the wire 36 is preferably surfacetreated or coated with a coating selected from the group consisting oftitanium nitride, iridium oxide, platinum black, and carbon nanotubes tocreate a surface texture that enhances the characteristics of thetissue-electrode interface to decrease post pulse delivery polarizationand stabilizes impedance changes. Advantageously, the coating or surfacetreatment can be done prior to application of the coating 42 ofinsulating material on the inner helical surface as described furtherbelow. Alternatively, the coating or surface treatment on theuninsulated outer helical electrode 40 can be done following applicationof the coating 42 of insulating material on the inner helical surface.

In the coating methods of the present invention, a layer of insulationis applied over at least a portion of an inner helical surface of eachcoil turn disposed toward the helix lumen, whereby at least a portion ofan outer helical surface of each coil turn is uninsulated. The methodsof applying the insulating material can be undertaken when the coil 37is a separate piece part, that is, prior to attachment of the coil 37 tothe lead body. This approach may be necessary when the fixation helix isadapted to be advanced from a cavity or chamber in the distal end of thelead body as described above. Alternatively, the methods of applying theinsulating material can be undertaken after the coil 37 is affixed tothe lead body to extend distally in the manner depicted in the fixedhelix pacing lead depicted in FIG. 2. For convenience, it will beassumed that the methods of applying the insulating material arepracticed to complete the fabrication of the fixation helix 25 as apiece part to be attached to the lead body and the distal end of anelectrical conductor in the lead body.

Turning to FIGS. 5 and 6, a masking tube 60 having a tube wall 62, atube lumen 64, a tube length at least as long as the coil 37, and amasking tube lumen diameter correlated with the helix outer diameter ODis provided. An interference fit between the outer helical surface ofthe wire coil 37 and the masking tube lumen diameter is preferred. Themasking tube 60 is preferably formed of a flexible polymer material,e.g., silicone rubber, that stretches to be receive the coil 37. In thisway, the coil 37 fits into the masking tube lumen 64 providing a maskedouter helical surface 44 of each coil turn in intimate contact with thetube wall 62 and an inner helical surface 46 exposed to coating with theinsulating material. Preferably, at least a portion of the adjacent coilturns that face one another are exposed within the masking tube lumen64.

Then, a polymer from among the group consisting of silicone rubber,parylene, polyurethane, polyacrylate, polymethacrylate, polyester,polyamide, polyether, polysiloxane, and polyepoxide is deposited uponthe inner helical surface of each coil turn within the masking tubelumen 64. For example, the assembly of the masking tube 60, the coil 37,and the crimp tube 50 are placed in a vacuum chamber of a parylenevacuum deposition system that delivers poly-paraxylylene into the vacuumchamber. A parylene coating is deposited upon the exposed inner helicalsurface 46 to form the inner helical insulating coating 42.

The masking tube 60 is removed after the coating has solidified, andresulting fixation helix 25 shown in FIGS. 7 and 8 now has an exposed,uninsulated outer helical electrode 40 in the area of the masked outerhelical surface 44 and an insulating coating 42 over the exposed innerhelical surface 46. The fixation helix 25 is then assembled to the leadbody in accordance with the methods employed to fabricate any particularelectrical medical lead, e.g., the pacing lead 20 of FIG. 2. As notedabove, the process illustrated in FIGS. 3-8 can be applied to a coil 37that is already affixed to the distal end of a lead body, particularlyif the coil 37 is not retractable into and extendable from a distalcavity of the lead body.

An alternative fabrication method is depicted in FIGS. 9 and 10 thatresults in the fixation helix 125 depicted in FIGS. 11 and 12, having aninterrupted outer helical electrode 140. In this method, the maskingtube 160 is formed having a tube wall 162, a tube lumen 164, a tubelength at least as long as the coil 37, and a masking tube lumendiameter correlated with the helix outer diameter OD is provided. Anelongated aperture 170 is provided through the tube wall 162 thatexposes one or more area or portion of the outer surface 44. In thedepicted example, the aperture 170 comprises a slit through the tubewall 162 extending substantially the length of the masking tube 160. Themasking tube 160 is dimensioned to provide an interference fit betweenthe outer helical surface 44 of the wire coil 37 and the masking tubewall 162. Again, the masking tube 160 is preferably formed of a flexiblepolymer material, e.g., silicone rubber, that stretches to be receivethe coil 37. In this way, the coil 37 fits into the masking tube lumen164 providing a masked outer helical surface 144 of each coil turn inintimate contact with the tube wall 162 and an exposed inner helicalsurface 146 exposed to coating with the insulating material. Inaddition, a portion of each coil turn is exposed through the aperture170.

In this method, the parylene (or other polymer) coating is applied asdescribed above into the masking tube lumen 164 and is also appliedthrough the aperture 170 as shown in FIGS. 9 and 10. Again, the maskingtube 160 is removed, and the resulting coating material extends aroundthe circumference of the wire 36 of the coil turn crossing the aperture170 in bands 172, 174, 176.

As shown in FIGS. 11 and 12, the resulting fixation helix 125 has anouter helical electrode 140 that is interrupted by the insulating layerbands 172, 174, 176. The number and surface area of bands 172, 174, 176can be selectively controlled by selection of the length and width ofthe aperture 170 and by inclusion of further apertures around thecircumference of the masking tube 160. In this way, the resultingsurface area of the outer helical electrode 140 can be tailored as foundsuitable for any intended implantation site.

Thus, following fixation in the myocardium, the exposed outer helicalelectrodes 40 and 140 are directed toward viable, excitable myocardialcells, and battery energy can be conserved due to as pacing energy isdirected away from traumatized cells within the helix lumen and betweenthe spiral coil turns. The exposed electrode surface area can besubstantially reduced even for a small diameter fixation helix toachieve an optimal impedance due to the outward orientation of the outerhelical electrode surface that avoids delivering stimulation energy totraumatized tissue or myocardial cells within the helix lumen or betweenthe adjacent facing surfaces of the coil turns.

In preferred embodiments, the helix is formed of platinum metal or aplatinum alloy and the uninsulated helical outer surface is coated witha coating selected the a coating selected from the group consisting oftitanium nitride, iridium oxide, platinum black and carbon nanotubes.

Preferred embodiments of the present invention also include applying asteroid coating on fixation helices 25 and 125 that is applied during orfollowing their formation as described above. In this regard, onepreferable way of applying the steroid coating would be to molecularlybond the steroid with the insulating material, e.g., a silicone rubberor a polyurethane compound, that is deposited to form the coating.Alternatively, the steroid may be deposited onto the coating ofinsulating material before removing the masking tube 60 or 160. Suitablesteroids include derivatives of dexamethasone, such as the water-solublesteroid dexamethasone sodium phosphate, beclomethasone diproprionate,and dexamethasone acetate.

CONCLUSION

All patents and publications identified herein are incorporated hereinby reference in their entireties.

While particular embodiments of the invention have been disclosed hereinin detail, this has been done for the purposes of illustration only, andis not intended to limit the scope of the invention as defined in theclaims that follow. It is to be understood that various substitutions,alterations, or modifications can be made to the disclosed embodimentswithout departing from the spirit and scope of the claims. The abovedescribed implementations are simply those presently preferred orcontemplated by the inventors, and are not to be taken as limiting thepresent invention to the disclosed embodiments. It is therefore to beunderstood, that within the scope of the appended claims, the inventionmay be practiced otherwise than as specifically described withoutactually departing from the spirit and scope of the present invention.

1. An electrical medical lead adapted to be implanted within the body atan implantation site to conduct electrical stimulation from animplantable stimulator to the site and to conduct electrical signals ofthe body from the site to the implantable or external stimulatorcomprising: an elongated lead body extending from a lead body proximalend to a lead body distal end; a lead connector element at the lead bodyproximal end; a lead conductor enclosed within the lead body andelectrically coupled to the first lead connector element an activefixation helix attached to the lead body distal end electrically coupledto the lead conductor, the fixation helix comprising at least one coilturn wound about a helix lumen and extending distally from a helixattachment end to a helix tip shaped to penetrate body tissue when thehelix is screwed into body tissue to secure fixation to the implantationsite; and a layer of insulation covering at least a portion of an innerhelical surface of each coil turn disposed toward the helix lumen,whereby at least a portion of an outer helical surface of each coil turnis uninsulated, and the uninsulated outer helical surface functions asan outer helical electrode disposed toward body tissue away from thehelix lumen.
 2. The electrical medical lead of claim 1, wherein thefixation helix comprises a plurality of coil turns wound with a constantpitch and inner and outer diameter from the helix attachment end to thehelix tip thereby defining a space between facing surfaces of adjacentcoil turns, and the layer of insulation covers at least portions of thefacing surfaces.
 3. The electrical medical lead of claim 2, wherein thehelix is formed of platinum metal or a platinum alloy and theuninsulated helical outer surface is coated with a coating selected fromthe group consisting of titanium nitride, iridium oxide, platinum black,and carbon nanotubes
 4. The electrical medical lead of claim 2, whereinthe uninsulated helical outer surface is in a continuous band extendingsubstantially between the point of attachment to the helix tip.
 5. Theelectrical medical lead of claim 4, wherein the uninsulated helicalouter surface has a surface area in the range of about 10% to about 50%of the total surface area.
 6. The electrical medical lead of claim 2,wherein the uninsulated helical outer surface is interrupted by theinsulating layer applied along the helical outer surface between thepoint of attachment and the helix tip.
 7. The electrical medical lead ofclaim 6, wherein the uninsulated helical outer surface has a surfacearea in the range of about 10% to about 50% of the total surface area.8. The electrical medical lead of claim 1, wherein the helix is formedof platinum metal or a platinum alloy and the uninsulated helical outersurface is coated with a coating selected from the group consisting oftitanium nitride, iridium oxide, platinum black, and carbon nanotubes 9.The electrical medical lead of claim 1, wherein the uninsulated helicalouter surface is in a continuous band extending substantially betweenthe point of attachment to the helix tip.
 10. The electrical medicallead of claim 4, wherein the uninsulated helical outer surface has asurface area in the range of about 10% to about 50% of the total surfacearea.
 11. The electrical medical lead of claim 1, wherein theuninsulated helical outer surface is interrupted by the insulating layerapplied along the helical outer surface between the point of attachmentand the helix tip.
 12. The electrical medical lead of claim 11, whereinthe uninsulated helical outer surface has a surface area in the range ofabout 10% to about 50% of the total surface area.
 13. The electricalmedical lead of claim 1, wherein the uninsulated helical outer surfacehas a surface area in the range of about 10% to about 50% of the totalsurface area.
 14. The electrical medical lead of claim 13, wherein thehelix is formed of platinum metal or a platinum alloy the uninsulatedhelical outer surface is coated with a coating selected from the groupconsisting of titanium nitride, iridium oxide, platinum black, andcarbon nanotubes.
 16. The electrical medical lead of claim 1, whereinthe insulating layer is selected from the group consisting of siliconerubber, parylene, polyurethane, polyacrylate, polymethacrylate,polyester, polyamide, polyether, polysiloxane, and polyepoxide.
 17. Theelectrical medical lead of claim 1, wherein a steroid selected from thegroup consisting of derivatives of dexamethasone, dexamethasone sodiumphosphate, beclomethasone diproprionate, and dexamethasone acetate isapplied onto or incorporated into at least a portion of the insulatinglayer.
 18. A method of fabricating an electrical medical lead adapted tobe implanted within the body at an implantation site to conductelectrical stimulation from an implantable stimulator to the site and toconduct electrical signals of the body from the site to the implantableor external stimulator comprising: forming an elongated lead bodyextending from a lead body proximal end to a lead body distal endenclosing a lead conductor; forming a lead connector element at the leadbody proximal end; electrically coupling the lead conductor to the firstlead connector element fabricating an active fixation helix by: forminga conductive wire into a helix comprising at least one coil turn woundabout a helix lumen, the helix extending from a helix attachment end toa distal end terminating in a helix tip shaped to penetrate body tissuewhen the helix is screwed into body tissue to secure fixation to theimplantation site; and applying a layer of insulation over at least aportion of an inner helical surface of each coil turn disposed towardthe helix lumen, whereby at least a portion of an outer helical surfaceof each coil turn is uninsulated; attaching the fixation end of thefixation helix to the lead body distal end; and electrically couplingthe fixation helix to the lead conductor, whereby the uninsulated outerhelical surface is disposed toward body tissue away from the helix lumento function as an outer helical electrode.
 19. The method of claim 18,wherein: the helix forming step comprises forming a plurality of coilturns wound in a constant pitch and coil diameter defining a helix lumendiameter and a helix outer diameter and a space between facing surfacesof adjacent turns; and the applying step comprises: providing a maskingtube having a tube wall, a tube lumen, a tube length, and a tube lumendiameter correlated with the helix outer diameter; fitting the helixturns into the tube lumen with the outer helical surface of each coilturn in contact with the tube wall and masked by the masking tube; andapplying the insulating material into the tube lumen to cover the innerhelical surface of each coil turn within the tube lumen.
 20. The methodof claim 19, wherein the applying step comprises depositing a polymerselected from the group consisting of silicone rubber, parylene,polyurethane, polyacrylate, polymethacrylate, polyester, polyamide,polyether, polysiloxane, and polyepoxide upon the inner helical surfaceof each coil turn within the tube lumen.
 21. The method of claim 19,wherein the applying step comprises applying a steroid selected from thegroup consisting of derivatives of dexamethasone, dexamethasone sodiumphosphate, beclomethasone diproprionate, and dexamethasone acetate ontoor incorporated into at least a portion of the insulating layer.
 22. Themethod of claim 18, wherein: the helix forming step comprises forming aplurality of coil turns wound in a constant pitch and coil diameterdefining a helix lumen diameter and a helix outer diameter and a spacebetween facing surfaces of adjacent turns; and the applying stepcomprises: providing a masking tube having a tube wall, a tube lumen, atube length, a tube lumen diameter correlated with the helix outerdiameter, and at least one tube wall aperture through the tube wall tothe tube lumen; fitting the helix turns into the tube lumen with theouter helical surface of each coil turn in contact with the tube walland masked by the masking tube and at least one portion of the outerhelical surface exposed through the tube wall aperture; and applying theinsulating material into the tube lumen to cover the inner helicalsurface of each coil turn within the tube lumen and through the tubewall aperture, whereby the uninsulated helical outer surface isinterrupted by the insulating layer applied through the tube wallaperture onto the helical outer surface.
 23. The method of claim 22,wherein the applying step comprises depositing a polymer selected fromthe group consisting of silicone rubber, parylene, polyurethane,polyacrylate, polymethacrylate, polyester, polyamide, polyether,polysiloxane, and polyepoxide upon the inner helical surface of eachcoil turn within the tube lumen.
 24. The method of claim 22, wherein theapplying step comprises applying a steroid selected from the groupconsisting of derivatives of dexamethasone, dexamethasone sodiumphosphate, beclomethasone diproprionate, and dexamethasone acetate ontoor incorporated into at least a portion of the insulating layer.
 25. Themethod of claim 18, wherein the applying step comprises depositing apolymer selected from the group consisting of silicone rubber, parylene,polyurethane, polyacrylate, polymethacrylate, polyester, polyamide,polyether, polysiloxane, and polyepoxide upon the inner helical surfaceof each coil turn within the tube lumen.
 26. The method of claim 18,further comprising applying a steroid selected from the group consistingof derivatives of dexamethasone, dexamethasone sodium phosphate,beclomethasone diproprionate, and dexamethasone acetate onto orincorporated into at least a portion of the insulating layer.
 27. Themethod of claim 18, wherein the step of fabricating an active fixationhelix comprises forming a wire of platinum metal or a platinum alloyinto the coil and coating the coil outer surface with a coating selectedfrom the group consisting of titanium nitride, iridium oxide, platinumblack, and carbon nanotubes
 28. The method of claim 18, wherein theapplying step comprises applying the layer of insulation over at least aportion of an inner helical surface of each coil turn disposed towardthe helix lumen, the uninsulated helical outer surface is in acontinuous band extending substantially between the point of attachmentto the helix tip.
 29. The method of claim 28, wherein the applying stepcomprises applying the layer of insulation such that the uninsulatedhelical outer surface has a surface area in the range of about 10% toabout 50% of the total surface area of the helix.
 30. The method ofclaim 18, wherein the applying step comprises applying the layer ofinsulation over at least a portion of an inner helical surface of eachcoil turn disposed toward the helix lumen such that the uninsulatedhelical outer surface has a surface area in the range of about 10% toabout 50% of the total surface area of the helix.
 31. The method ofclaim 30, wherein the applying step comprises applying the layer ofinsulation over at least a portion of the helical outer surface.
 32. Themethod of claim 18, wherein the applying step comprises applying thelayer of insulation over at least a portion of the helical outersurface.